首家!仙琚製藥(002332.SZ)潑尼松龍片通過一致性評價
格隆匯7月4日丨仙琚製藥(002332.SZ)公佈,公司近日收到國家藥監局核准簽發的關於潑尼松龍片的《藥品補充申請批准通知書》(通知書編號:2022B02592),公司潑尼松龍片通過仿製藥質量和療效一致性評價。
潑尼松龍為糖皮質激素類藥物,超生理量的糖皮質激素具有抗炎、抗過敏和抑制免疫等多種藥理作用。主要用於過敏性與自身免疫性炎症性疾病,膠原性疾病。
公司潑尼松龍片(規格5mg)於1988年5月31日獲批上市,批准文號為:國藥準字H33021098。
公司表示,公司首家通過潑尼松龍片仿製藥質量和療效一致性評價,有利於提升產品市場競爭力,為公司後續藥品一致性評價工作積累經驗。
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